Financial Toxicity and Quality of Life in Patients With Testicular Germ Cell Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high.
研究概览
简要总结
This is a cross-sectional, observational study employing validated questionnaires to investigate financial toxicity in subjects with testicular germ cell tumors (TGCT). As background, TGCTs are the most common malignancies among men from age 15-35. Treatment is highly curative, but often consists of intensive multi-cycle chemotherapy with significant potential for physical toxicity. The treatment course itself is disruptive and long term physical and mental health consequences can increase risk for financial toxicity. Thus, we aim to study financial toxicity in both patients with TGCT actively receiving treatment and in TGCT survivors. There will be two separate cohorts: Cohort 1 will consist of subjects with recently diagnosed TGCT who will undergo multi-agent, multi-cycle chemotherapy and Cohort 2 will consist of subjects who have completed chemotherapy and are long-term survivors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years of age
- •Patients with histologically or clinically confirmed germ cell tumor.
- •Completed treatment for germ cell tumor with multicycle (> 2 cycles) / multiagent chemotherapy.
- •Within years 1-5 of surveillance since Day 1 of last cycle of chemotherapy
- •Signed informed consent
排除标准
- •Long-term survivors
- •Patients undergoing active chemotherapy
- •Patients who did not complete 1st line chemotherapy.
结局指标
主要结局
Number of patients undergoing treatment for newly diagnosed GCT and GCT patients who are currently in surveillance whose levels of financial toxicity are high.
时间窗: 5 years
次要结局
- Number and type of financial risk factors impacting low levels of health-related quality of life for patients with GCT.(5 years)